The present invention relates to forms and methods of using forms to record a chain of custody. More specifically, it relates to a composite form, e.g., one that is printed upon a single sheet, comprising removable seals that are integrated into the form. The invention also relates to methods of using such a form to record the handling of a specimen from the time of collection until arrival at the laboratory, thereby ensuring both the integrity of the specimen and the accountability of those who handle it.
The term “chain of custody” often refers to documenting the acquisition, handling, transfer, and/or disposition of an object or information. A chain of custody may be maintained, e.g., when an object needs to be protected from tampering. For example, a chain of custody may record the handling of a handgun found at a crime scene, from the finding of gun to the final disposition of any criminal charges. By identifying everyone who handled the gun, the chain of custody permits proof at trial that no one tampered with it, e.g., by altering fingerprints or damaging DNA that may be evidence of guilt. A chain of custody commonly includes both positively identifying everyone who handles the evidence and preventing unrecorded handling, and may include records relating to the conditions under which the evidence has been handled, e.g., transported and/or stored.
In the field of laboratory analysis of biological samples, maintaining a chain of custody often refers to documenting the identity and handling of a specimen from the time it is collected until it is delivered to the laboratory and, possibly, even to an analyst or technician within the laboratory. Proper maintenance of the chain of custody protects the integrity of testing by identifying anyone who might have an opportunity to tamper with a test sample and preventing tests on specimens that may have suffered contamination consequent to tampering by persons not responsible for collection, processing, or analysis of the samples. Ensuring the integrity of the process may be desirable, e.g., when the test results may have serious legal and/or economic consequences, such as when the specimen is a urine, blood, oral fluid (e.g., saliva), sweat, or hair sample that is to be tested for evidence of the donor's drug use.
Maintaining a chain of custody often involves requiring each individual involved in each transfer of the samples to record the time and date of transfer on a signed chain of custody form. The form thereby documents the transfer of the specimen from the collector or other test administrator, often through another person, such as a courier, to the analyst at the laboratory. The process often includes strict security procedures to prevent tampering or contamination. For example, a container is typically sealed with a tamper-evident adhesive seal immediately after collection. If an analyst or other representative at the laboratory determines from the apparent condition of the seal that it has been tampered with, the sample will not be tested.
According to the prior art, the chain of custody is recorded on documents that create multiple identical sheets using carbon or carbonless paper, which are typically filled out by hand. The multiple sheets are commonly used to provide a record of the collection event to some or all parties involved in collection and testing, e.g., the collector, the employer or other requesting authority, the donor, the laboratory, and/or the Medical Review Officer) Conventional label printers may also generate sheets of specimen seals that include identification codes in human-readable (e.g., printed alphanumeric characters) and/or machine-readable (e.g., bar code) formats.